UnitedHealthcare Pharmacy Clinical Pharmacy Programs - Tremfya

Coverage Summary

UnitedHealthcare prior authorization and medical necessity criteria apply to subcutaneous Tremfya (guselkumab) for: plaque psoriasis, psoriatic arthritis, moderately to severely active ulcerative colitis, and moderately to severely active Crohn's disease. The policy is covered with criteria and became effective 2025-12-01 with last review on 2025-10-01. Authorizations (initial and reauthorization) are issued for 12 months. The policy covers 4 indications specified above and includes initial and reauthorization requirements, prescriber specialty requirements, and combination therapy exclusions.

Plaque Psoriasis — Initial Authorization

Plaque Psoriasis - Initial Authorization

Tremfya will be approved based on all of the following criteria:

ALL of the following

Diagnosis of moderate to severe plaque psoriasis
One of the following
- A
  - Greater than or equal to 3% body surface area involvement, palmoplantar, facial, genital involvement, or severe scalp psoriasis
  - History of failure to one of the following topical therapies, unless contraindicated or clinically significant adverse effects are experienced (document drug, date, and duration of trial): corticosteroids (e.g., betamethasone, clobetasol, desonide), vitamin D analogs (e.g., calcitriol, calcipotriene), tazarotene, calcineurin inhibitors (e.g., tacrolimus, pimecrolimus), anthralin, coal tar
  - History of failure to a 3 month trial of methotrexate at maximally indicated dose, unless contraindicated or clinically significant adverse effects are experienced (document date and duration of trial)3 months
    maximally indicated dose
- B
  - Patient has been previously treated with a targeted immunomodulator FDA-approved for the treatment of plaque psoriasis as documented by claims history or submission of medical records (document drug, date, and duration of therapy) (examples: Cimzia (certolizumab), adalimumab, Otezla (apremilast), Skyrizi (risankizumab), ustekinumab)
  - C (current user exception)
    Patient is currently on Tremfya therapy as documented by claims history or submission of medical records (Document date and duration of therapy)
    Patient has not received a manufacturer supplied sample at no cost in the prescriber's office, or any form of assistance from the Janssen sponsored CarePath Savings program as a means to establish as a current user of Tremfya
Patient is not receiving Tremfya in combination with another targeted immunomodulator (examples listed in policy)
Prescribed by or in consultation with a dermatologist

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Plaque Psoriasis — Reauthorization / Continuation

Plaque Psoriasis - Reauthorization

Tremfya will be approved based on all of the following criteria:

ALL of the following

Documentation of positive clinical response to Tremfya therapy
Patient is not receiving Tremfya in combination with another targeted immunomodulator (examples listed in policy)

Psoriatic Arthritis — Initial Authorization

Psoriatic Arthritis - Initial Authorization

Tremfya will be approved based on all of the following criteria:

ALL of the following

Diagnosis of active psoriatic arthritis
One of the following
- History of failure to a 3 month trial of methotrexate at the maximally indicated dose, unless contraindicated or clinically significant adverse effects are experienced (document date and duration of trial)3 months
  maximally indicated dose
- Patient has been previously treated with a targeted immunomodulator FDA-approved for the treatment of psoriatic arthritis as documented by claims history or submission of medical records (Document drug, date and duration of therapy) (examples: Cimzia (certolizumab), adalimumab, Simponi (golimumab), ustekinumab, Xeljanz (tofacitinib), Otezla (apremilast), Rinvoq (upadacitinib))

Psoriatic Arthritis — Reauthorization / Continuation

Psoriatic Arthritis - Reauthorization

Tremfya will be approved based on all of the following criteria:

ALL of the following

Documentation of positive clinical response to Tremfya therapy
Patient is not receiving Tremfya in combination with another targeted immunomodulator (examples listed in policy)

Ulcerative Colitis — Initial Authorization

Ulcerative Colitis - Initial Authorization

Tremfya will be approved based on all of the following criteria:

ALL of the following

Diagnosis of moderately to severely active ulcerative colitis
One of the following
- Patient has been approved for loading dose of Tremfya under an active UnitedHealthcare medical benefit prior authorization for the treatment of moderately to severely active ulcerative colitis
- B
  - Patient has had prior or concurrent inadequate response to a therapeutic course of oral corticosteroids and/or immunosuppressants (e.g., azathioprine, 6-mercaptopurine)

Ulcerative Colitis — Reauthorization / Continuation

Ulcerative Colitis - Reauthorization

Tremfya will be approved based on both of the following criteria:

ALL of the following

Documentation of positive clinical response to Tremfya therapy
Patient is not receiving Tremfya in combination with another targeted immunomodulator (examples listed in policy)

Crohn's Disease — Initial Authorization

Crohn's Disease - Initial Authorization

Tremfya will be approved based on all of the following criteria:

ALL of the following

Diagnosis of moderately to severely active Crohn's disease
One of the following
- Patient has been approved for loading dose of Tremfya under an active UnitedHealthcare medical benefit prior authorization for the treatment of moderately to severely active Crohn's disease
- B
  - History of failure to one of the following conventional therapies at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced (document drug, date and duration of trial): corticosteroids (e.g., prednisone, methylprednisolone, budesonide), 6-mercaptopurine (Purinethol), azathioprine (Imuran), methotrexate (Rheumatrex, Trexall)

Crohn's Disease — Reauthorization / Continuation

Crohn's Disease - Reauthorization

Tremfya will be approved based on both of the following criteria:

ALL of the following

Documentation of positive clinical response to Tremfya therapy
Patient is not receiving Tremfya in combination with another targeted immunomodulator (examples listed in policy)

Combination Therapy Exclusion / Targeted Immunomodulators

The policy requires that a patient is not receiving Tremfya in combination with another targeted immunomodulator. Examples of targeted immunomodulators listed in the policy include: Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), Orencia (abatacept), adalimumab, ustekinumab, Skyrizi (risankizumab), Cosentyx (secukinumab), Taltz (ixekizumab), Siliq (brodalumab), Ilumya (tildrakizumab), Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib), Otezla (apremilast).

Examples of targeted immunomodulators (combination therapy exclusion list)mixedNot Covered

	Enbrel (etanercept)
	Cimzia (certolizumab)
	Simponi (golimumab)
	Orencia (abatacept)
	adalimumab
	ustekinumab
	Skyrizi (risankizumab)
	Cosentyx (secukinumab)
	Taltz (ixekizumab)
	Siliq (brodalumab)

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Provider Actions & Authorization Workflow

Prior Authorization

Prior authorization required

Initial and reauthorization approvals require submission of documentation per the policy criteria (diagnosis, prior therapies, trial dates and durations, and evidence of prior targeted immunomodulator use or current Tremfya use). Authorizations are issued for 12 months.

Documentation Required

Document prior therapy trials

Document prior therapy trials including topical agents, methotrexate (when applicable), conventional Crohn's therapies (when applicable), and prior targeted immunomodulator therapy. For each trial, provide the drug name, date(s) and duration. Claims history may be used to document prior targeted immunomodulator use or current Tremfya therapy.

Required trial details: drug name, date(s) of trial, and duration of trial
Topical therapy trials (e.g., corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors, anthralin, coal tar) — document drug, date, duration

Background & Clinical References

Tremfya (guselkumab) is an interleukin-23 blocker indicated for moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis, and moderately to severely active Crohn's disease. This policy applies to the subcutaneous formulations of Tremfya. The package insert primary reference is Tremfya [package insert], Janssen Biotech Inc.; September 2025. The policy's P&T approval dates include 5/2020, 11/2020, 6/2021, 12/2021, 12/2022, 3/2023, 7/2023, 10/2024, 11/2024, 3/2025, 10/2025. Note: ulcerative colitis coverage criteria were added in 11/2024 and later updated to allow for newly approved subcutaneous induction dosing (10/2025).

Definitions

Current user exception: Patients currently on Tremfya documented by claims or medical records may bypass some step requirements, provided documentation is submitted; manufacturer samples or CarePath assistance do not qualify as documentation of current use.

Revision History

2024-11addition

Added coverage criteria for ulcerative colitis (UC) to the Tremfya prior authorization policy.

2025-03update

Referenced and updated background related to the added ulcerative colitis criteria.

2025-10update

Updated ulcerative colitis criteria to allow for newly approved subcutaneous induction dosing.